Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

Pancreatic Disease Clinical Trial

Official title:

A Pilot Study Evaluating Health-related Quality of Life Endpoints in Patients Undergoing Minimally Invasive Versus Open Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638818
• Other study ID #: Pro00064629
• Status: Completed
• Start date: July 25, 2016
• Est. completion date: September 10, 2019

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the impact of the quality of life in patients undergoing the Whipple procedure (pancreaticoduodenectomy, PD) for pancreatic cancer. The Whipple procedure can be done by laparoscopic (small incisions) or an open procedure (large incision) to treat the patients cancer. The goal of this study is to see if there is any difference in quality of life between patients who undergo the laparoscopic or the open Whipple procedure. Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.

A subset of these patients will also be asked to take part in a pre- and postoperative in-depth interview to explore the lived experiences of patients with resectable pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients scheduled for pancreaticoduodenectomy will be eligible for this study.

• Subject must be at least 18 years of age and at least the minimum Age of Majority according to applicable State or Country Law.

• Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia and PD for diagnosis of cancer

• Subject is willing and able to cooperate with survey participation.

• Subject has been informed of the study procedures and the treatment and has signed an informed consent form

Exclusion Criteria:

• Subject is not a suitable candidate for PD

Related Conditions & MeSH terms

• Pancreatic Disease
• Pancreatic Diseases

Intervention

Procedure:
• minimally invasive pancreaticoduodenectomy
Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.
• traditional pancreaticoduodenectomy
Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life, as measured by FACT-Hep score	The summed overall FACT-Hep score (0-180) will be the primary outcome.	Baseline (before surgery), at hospital discharge (up to approximately 14 days), at first clinic visit (within 2 weeks after discharge), 3 months